All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Peripheral Vascular Disease (“PVD”), also referred to as Peripheral Arterial Disease (“PAD”), is a general term for diseases caused by occlusion or obstruction of peripheral arteries. PVD is a common disease affecting numerous patients that may lead to morbidity and suffering. The occlusion of peripheral arteries via the processes of atherosclerosis, inflammatory response, embolism, thrombus formation and diabetes mellitus may all result in PVD. PVD may cause acute or chronic ischemia in the surrounding tissues, particularly in an extremity of the affected person. The acute or chronic ischemia may result in pain in the extremity (e.g., claudication), loss of sensation in the extremity, sores, wounds or ulcers that heal slowly or not at all, and tissue loss in the affected extremity. Ischemia is characterized by an absolute or relative shortage of blood supply to a tissue as a result of constricted or blocked blood vessels supplying the tissue.
The technology available to treat ischemia in an extremity includes invasive surgical arterial bypass operations, peripheral arterial balloon angioplasty and stent placement. However, in many patients and especially in those with diabetes mellitus, the occlusive disease affects small blood vessels that are not amenable to mechanical revascularization. Current technology tends to have limited long term success with high recurrence rates. Medical therapy is also available; however, the benefit is limited. The most severe cases require amputation of the extremity.
Thus, there is a need in the art for a method and a device for non-invasive treatment of ischemia and/or PVD. Further, there is a need for technology to enhance perfusion to the extremities, to enhance a body's ability to develop collateral blood vessels and to enhance collateral circulation.